A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
SSRIs/SNRIs+Mood Stabilizer
SSRIs/SNRIs+Quetiapine
Usual Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 16-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- Be necessary and suitable to accept the treatment of antidepressants;
- Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
- With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.
Exclusion Criteria:
- Severe medical or neurological problems;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
- Had ECT, MECT or rTMS in the past 6 months;
- Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.
Sites / Locations
- Guangzhou Psychiatric Hospital
- Wuhan Mental Health Center
- Dalian Seventh People's Hospital
- Shanghai Mental Health CenterRecruiting
- Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
No Intervention
Arm Label
FAD
RAD
BD
HC
Arm Description
the first-episode major depressive disorder with atypical feature
the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks
the depressive episode of bipolar disorder
healthy control
Outcomes
Primary Outcome Measures
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 24 items
switch rate
the rate of patients who switch from depression to mania or hypomania during 4-year follow-up
Secondary Outcome Measures
Full Information
NCT ID
NCT04209166
First Posted
December 16, 2019
Last Updated
December 20, 2019
Sponsor
Shanghai Mental Health Center
Collaborators
Air Force Military Medical University, China, Guangzhou Psychiatric Hospital, Dalian Seventh People's Hospital, Wuhan Union Hospital, China, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04209166
Brief Title
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
Official Title
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Air Force Military Medical University, China, Guangzhou Psychiatric Hospital, Dalian Seventh People's Hospital, Wuhan Union Hospital, China, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The lifetime prevalence of major depressive disorder (MDD) is 10%~20%. Worldwide, nearly 340 million individuals have suffered the torture of depression. World Health Organization has reported that MDD would become the most serious global burden of disease and eventually turn into a public health problem in 2030. Varied clinical symptoms, inappropriate treatment, unclear pathogenesis, and lack of recurrent risk early-warning predictors cause a series of clinical problems, such as low diagnostic rate, low effective treatment rate, and high recurrent rate. Hence, this study aims to search multidimensional markers for early diagnosis of MDD, to establish optimized personalized therapy, and to explore sensitive recurrence predictors.
Based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), MDD is subdivided into eight different clinical specifiers, one of which the incident rate of MDD with atypical features reaches 30%~38%. However, there is still a lack of meta-evidence for the clinical treatment strategy in MDD with atypical features. And 45.4 percentage of MDD with atypical features convert to bipolar disorder. Therefore, this study will focus on three issues about what's the objective endophenotype in MDD with atypical features, how to select appropriate personalized treatment for MDD with atypical features, what's the predictive biomarker of conversion to bipolar disorder.
Based on the investigators' previous findings, this study will investigate adult depression at a cross-sectional study and a prospective cohort study. Multivariate informatics analysis was performed from three research dimensions (cognitive neuropsychology, metabonomics, and multimodal neuroimaging), including atypical features, "cold/hot" cognition assessment, KP (kynurenine pathway) metabolomics and inflammatory factors, multimodal MRI robust property. Referring guidelines for the diagnosis and treatment of depression and evidence-based medicine evidence, MDD with atypical features are divided into f groups (antidepressants, antidepressants+mood stabilizers, mood stabilizers, treat as usual). Then, the investigators perform follow-up to verify optimized treatment strategies and to explore risk factors of conversion from MDD with atypical features to bipolar disorder. Furthermore, this study performs correlation analysis to analyze cross-omics data, weight coefficient analysis to analyze multidimensional indexes, clustering analysis to analyze multivariate bio-information data, and artificial intelligence technologies (such as pattern recognition, and machine learning) to realize the transformation from medical data to practical transformation. Eventually, this study builds three specific models (the multidimensional early diagnosis models for MDD with atypical features, the optimized personalized therapy model, and the recurrence and conversion risk early-warning model), which form the integrated intelligent platform for multidimensional diagnosis, personalized treatment, recovery management of MDD with atypical features.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
780 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FAD
Arm Type
Experimental
Arm Description
the first-episode major depressive disorder with atypical feature
Arm Title
RAD
Arm Type
Experimental
Arm Description
the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks
Arm Title
BD
Arm Type
No Intervention
Arm Description
the depressive episode of bipolar disorder
Arm Title
HC
Arm Type
No Intervention
Arm Description
healthy control
Intervention Type
Drug
Intervention Name(s)
SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
Intervention Description
Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Intervention Type
Drug
Intervention Name(s)
SSRIs/SNRIs+Mood Stabilizer
Intervention Description
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Intervention Type
Drug
Intervention Name(s)
SSRIs/SNRIs+Quetiapine
Intervention Description
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Intervention Type
Drug
Intervention Name(s)
Usual Treatment
Intervention Description
Patients' treatment will be decided by the clinical doctor.
Primary Outcome Measure Information:
Title
remission of acute phase
Description
scored 7 or lower on the Hamilton's Depression Scale with 24 items
Time Frame
12th week
Title
switch rate
Description
the rate of patients who switch from depression to mania or hypomania during 4-year follow-up
Time Frame
4th year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
16-60 years old;
Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
With enough audio-visual ability and comprehensive ability to accomplish the visits;
Be necessary and suitable to accept the treatment of antidepressants;
Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.
Exclusion Criteria:
Severe medical or neurological problems;
Previous mania or hypomania episodes;
Female patients who are pregnant, planning to be pregnant or breastfeeding;
Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
Had ECT, MECT or rTMS in the past 6 months;
Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daihui Peng, MD. PhD.
Phone
18017311136
Email
pdhsh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daihui Peng, MD. PhD.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou Psychiatric Hospital
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiyun Xu, MD
Phone
18922165291
Email
13650774898@163.com
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li, MD
Phone
13554013182
Email
psylee@163.com
Facility Name
Dalian Seventh People's Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoufu Xie, MD
Phone
13998622066
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daihui Peng, M.D.,Ph.D.
Phone
18017311136
Email
pdhsh@126.com
Facility Name
Fourth Military Medical University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaning Wang, MD
Phone
13609161341
Email
13609161341@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
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